Lichen Planus: Cutaneous Lichen Planus, Mucosal Lichen Planus and Lichen Planopilaris
Conditions
Keywords
Lichen planus, CLP, MLP, LPP
Brief summary
The primary purpose of the proof of concept study is to elucidate the efficacy of secukinumab in the treatment of adult patients with biopsy-proven lichen planus not adequately controlled by topical therapies, and to assess the safety and tolerability over 32 weeks.
Detailed description
This was a 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial which assessed the efficacy and safety of secukinumab 300 mg in two different dosing regimens: every 4 weeks (Q4W) and every 2 weeks (Q2W) in approximately 111 patients with biopsy-proven forms of lichen planus. There was a screening period (up to 4 weeks prior to baseline), a treatment period 1 (baseline to Week 16), a treatment period 2 (Week 16 to Week 32) and a follow-up period (8 weeks after Week 32).
Interventions
DRUGsecukinumab 300 mg Q4W
secukinumab 300 mg administered every four weeks (Q4W) via a pre-filled syringe.
DRUGsecukinumab 300 mg Q2W
secukinumab 300 mg administered every two weeks (Q2W) via a pre-filled syringe.
OTHERPlacebo
Matching placebo administered via a pre-filled syringe
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
PoC study, 32-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial assessing the efficacy and safety of secukinumab 300 mg in two different dosing regimens in 108 patients with biopsy-proven forms of lichen planus.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Written informed consent must be obtained before any assessment is performed. 2. Female and male patients ≥ 18 years of age. 3. Subjects must have biopsy-confirmed forms of cutaneous lichen planus (CLP), mucosal lichen planus (MLP), or active lichen planopilaris (LPP) eligible for systemic therapy based on the following criteria: * rated IGA of ≥ 3 (moderate or severe) AND * inadequate response to topical corticosteroids of high-ultrahigh potency in the opinion of the investigator. 4. If using any of the allowed topical treatments on the affected areas, the dose and application frequency should remain stable for 2 weeks prior to randomization and until Week 16.
Exclusion criteria
1. Clinical history suspicious for lichenoid drug eruption. 2. Lichen planus pigmentosus. 3. Clinical picture or history suspicious of paraneoplastic mucosal lichen planus. 4. Subjects whose lichen planus is a predominantly bullous variant. 5. Mucosal LP of the oral cavity or gastrointestinal involvement requiring the patient to use parenteral nutrition or feeding tube. 6. Clinical picture of scarring alopecia without active inflammation. 7. Clinical picture of burnt-out cicatricial alopecia (alopecia of Brocque). 8. Patients diagnosed with frontal fibrosing alopecia (FFA) without active patches of LPP 9. Clinical picture of LPP in patients who have already failed 3 or more systemic immunosuppressive or immunomodulatory agents (e.g. systemic steroids, hydroxychloroquine, cyclosporine, methotrexate and mycophenolate mofetil). 10. Currently enrolled in any other clinical trial involving any investigational agent or device. 11. Previous exposure to any other biologic drug directly targeting IL-17A or IL-17RA (e.g. secukinumab, ixekizumab or brodalumab) or IL-23/p19 (e.g. tildrakizumab, guselkumab, risankizumab). 12. Diagnosis of active infectious diseases of the skin, scalp or mucosa (for example bacterial, viral or fungal infections of the mouth) that may interfere with the assessment of the study disease or require treatment with prohibited medications. 13. Diagnosis of active inflammatory diseases of the skin, scalp or mucosa other than lichen planus that may interfere with the assessment of the study disease or require treatment with prohibited medications. 14. Presence of any other skin condition that may affect the evaluations of the study disease. 15. Underlying conditions (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) and/or presence of laboratory abnormalities which in the opinion of the investigator significantly immunocompromises the subject and/or places the subject at unacceptable risk for receiving an immunomodulatory therapy. 16. Current, severe, progressive or uncontrolled diseases that render the patient unsuitable for the trial, including any medical or psychiatric condition that, in the Investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | Baseline up to week 16 | Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method based on beta-binomial model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32 | Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. |
| Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32 | Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. |
| Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32 | The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50% of total body surface |
| Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32 | The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment. |
| Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32 | The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment. |
| Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32 | The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment. |
| Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable. |
| Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable. |
| Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32 | Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score. |
| Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable. |
| Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable. |
| Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable. |
| Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Baseline, Week 16 and Week 32 | REU measured disease severity based on 3 dimensions: reticulation, erythema and ulceration for all subjects in the MLP cohort who had an oral presentation of the disease. The total score ranged from 0-115 with higher values corresponding to higher activity of the disease. |
| Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Baseline, Week 16 and Week 32 | OLPSSM is a self-administered assessment of the symptom experience of subjects with oral LP in clinical studies. It includes 7 triggers contributing to soreness of oral lichen planus: Brushing teeth, eating food, drinking liquids, smiling, breathing through mouth, talking and touching. These 7 items contributed equally to a total OLP symptom severity score, ranging from 0 to 28, with higher scores indicating worse severity. |
| Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | The LPPAI assesses symptoms (pruritus, pain, burning), signs (erythema, perifollicular erythema and scale), a measure of activity (pull test) and extension of disease. These subjective and objective measures are assigned numeric values to establish a disease activity score. The total score ranges from 0 to 10, with higher scores corresponding to higher disease activity |
| Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Scalpdex is a self-administered, health-related quality of life instrument originally developed for scalp dermatitis. This survey includes 23 items, each item scored on a scale of 0-100, where 0=never, 25=rarely, 50=sometimes, 75=often and 100=all the time. The 23 items pertain to 3 domains: symptom, emotions and functioning. Subjects were asked to score themselves on how true each of the 23 statements has been for them over the past four weeks. the total score is the average of the scores of the 23 items. A higher total score indicated a higher impairment in quality of life. |
| Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline, Week 16 and Week 32 | Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable. |
Countries
France, Germany, United States
Participant flow
Pre-assignment details
163 subjects (3 cohorts) were screened and 111 were randomized. Subjects in the AIN457 300 mg Q4W group in TP1 continued on AIN457 300mg Q4W in TP2. Subjects in the Placebo group in TP1 received AIN457 300mg Q2W in TP2. Patients in the Placebo group with spontaneous remission at Week 16 entered the Follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe | 25 |
| Placebo - TP 1 - CLP Cohort Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe | 12 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort AIN457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe | 24 |
| Placebo - TP 1 - MLP Cohort Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe | 13 |
| AIN457 300 mg Q4W - TP 1 - LPP Cohort AIN457457 300 mg every 4 weeks up to 16 weeks administered via a pre-filled syringe | 24 |
| Placebo - TP 1 - LPP Cohort Matching placebo administered every 4 weeks up to 16 weeks via a pre-filled syringe | 13 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment Period 1: Baseline to 16 Weeks | Adverse Event | 0 | 0 | 0 | 0 | 1 | 0 |
| Treatment Period 1: Baseline to 16 Weeks | Progressive disease | 1 | 0 | 0 | 0 | 0 | 0 |
| Treatment Period 1: Baseline to 16 Weeks | Subject/guardian decision | 1 | 2 | 0 | 0 | 0 | 1 |
| Treatment Period 2: 16 to 32 Weeks | Adverse Event | 1 | 0 | 2 | 0 | 1 | 0 |
| Treatment Period 2: 16 to 32 Weeks | Progressive disease | 2 | 0 | 1 | 0 | 2 | 0 |
| Treatment Period 2: 16 to 32 Weeks | Protocol deviation | 0 | 1 | 0 | 0 | 0 | 0 |
| Treatment Period 2: 16 to 32 Weeks | Subject/guardian decision | 2 | 0 | 1 | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | AIN457 300 mg Q4W - TP 1 - CLP Cohort | Placebo - TP 1 - CLP Cohort | AIN457 300 mg Q4W - TP 1 - MLP Cohort | Placebo - TP 1 - MLP Cohort | AIN457 300 mg Q4W - TP 1 - LPP Cohort | Placebo - TP 1 - LPP Cohort | Total |
|---|---|---|---|---|---|---|---|
| Age, Customized 18 to <65 years | 22 Participants | 9 Participants | 14 Participants | 8 Participants | 19 Participants | 12 Participants | 84 Participants |
| Age, Customized > or = 65 years | 3 Participants | 3 Participants | 10 Participants | 5 Participants | 5 Participants | 1 Participants | 27 Participants |
| Baseline of Investigator's Global Assessment (IGA) 0=Clear | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline of Investigator's Global Assessment (IGA) 1=Minimal | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Baseline of Investigator's Global Assessment (IGA) 2=Mild | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Baseline of Investigator's Global Assessment (IGA) 3=Moderate | 16 Participants | 9 Participants | 22 Participants | 8 Participants | 17 Participants | 10 Participants | 82 Participants |
| Baseline of Investigator's Global Assessment (IGA) 4=Severe | 8 Participants | 3 Participants | 2 Participants | 5 Participants | 7 Participants | 3 Participants | 28 Participants |
| Race/Ethnicity, Customized Asian (Indian) | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 14 Participants |
| Race/Ethnicity, Customized White | 19 Participants | 8 Participants | 19 Participants | 12 Participants | 23 Participants | 13 Participants | 94 Participants |
| Race/Ethnicity, Customized White, American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 15 Participants | 8 Participants | 14 Participants | 12 Participants | 20 Participants | 10 Participants | 79 Participants |
| Sex: Female, Male Male | 10 Participants | 4 Participants | 10 Participants | 1 Participants | 4 Participants | 3 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 12 | 0 / 33 | 0 / 8 | 0 / 24 | 0 / 13 | 0 / 35 | 0 / 11 | 0 / 24 | 0 / 13 | 0 / 36 | 0 / 12 |
| other Total, other adverse events | 15 / 25 | 7 / 12 | 21 / 33 | 6 / 8 | 18 / 24 | 8 / 13 | 26 / 35 | 8 / 11 | 16 / 24 | 7 / 13 | 22 / 36 | 6 / 12 |
| serious Total, serious adverse events | 0 / 25 | 1 / 12 | 0 / 33 | 0 / 8 | 1 / 24 | 0 / 13 | 2 / 35 | 1 / 11 | 0 / 24 | 1 / 13 | 1 / 36 | 1 / 12 |
Outcome results
Primary
Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP
Number of treatment responders at week 16, where response is defined as an Investigator's Global Assessment (IGA) score of 2 or lower at Week 16. IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Minimal; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best score and 4 being worst score. CLP=Cutaneous lichen planus, MLP=Mucosal lichen planus, LPP=Lichen planopilaris. Posterior median and 95% credible interval (instead of 95% confidence interval) were derived using Bayesian method based on beta-binomial model.
Time frame: Baseline up to week 16
Population: Full analysis set of participants with a baseline IGA score \>= 3 were included
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | 44.0 percentage of participants |
| Placebo - TP 1 - CLP Cohort | Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | 58.2 percentage of participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | 37.5 percentage of participants |
| Placebo - TP 1 - MLP Cohort | Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | 23.1 percentage of participants |
| AIN457 300 mg Q4W - TP 1 - LPP Cohort | Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | 37.6 percentage of participants |
| Placebo - TP 1 - LPP Cohort | Response Rate of Investigator Global Assessment (IGA) Score of 2 or Lower at Week 16 for CLP, MLP and LPP | 30.9 percentage of participants |
95% CI: [-44.8, 19.3]
95% CI: [-17, 40.7]
95% CI: [-25.4, 35.4]
Secondary
Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS)
The Physician Assessment of Surface Area of Disease (PSAD) evaluates the extent of cutaneous lesions estimated by investigator or qualified designee. Assessment scores range from 0-5, with lower scores corresponding to lower percentages of surface area with disease: 0=clear, 1=\<2%, 2=2-9%, 3=10-29%, 4=30-50%, 5=\>50% of total body surface
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 4 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 3 score | 9 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 4 score | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 3 score | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 4 score | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 5 score | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 1 score | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 4 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 1 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 2 score | 8 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 3 score | 8 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 4 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 1 score | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 2 score | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 3 score | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 3 score | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 1 score | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 2 score | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 4 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 1 score | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 2 score | 12 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 3 score | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 4 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 1 score | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 2 score | 12 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 3 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 4 score | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 0 score | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 1 score | 8 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 2 score | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 3 score | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 2 score | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 5 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 1 score | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 2 score | 11 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 3 score | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 4 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 0 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 1 score | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 2 score | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 3 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 4 score | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 5 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 0 Score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 1 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 2 score | 6 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 4 score | 4 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 2 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 4 score | 4 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 3 score | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 4 score | 6 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 5 score | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 5 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 0 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 1 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 3 score | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 4 score | 5 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 5 score | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 0 Score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 0 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 1 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 2 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 3 score | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 4 score | 5 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 4 5 score | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 0 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 1 score | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 2 score | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 3 score | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 8 5 score | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 0 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 1 score | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 2 score | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 3 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 4 score | 7 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Baseline 1 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 12 5 score | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 0 score | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 1 score | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 2 score | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 2 score | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 3 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 1 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 1 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 4 score | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 3 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 2 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 4 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 1 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 3 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 4 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 2 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 3 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 2 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 4 score | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 1 score | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 3 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 2 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 2 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 16 5 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 2 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 4 score | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 28 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 3 score | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 0 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 32 5 score | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 24 1 score | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects in Each Category in Physician´s Assessment of Surface Area of Disease (PSAD) - CLP (BOCF) - Entire Treatment Period (FAS) | Week 20 5 score | 2 Participants |
Secondary
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS)
The Dermatology Life Quality Index (DLQI) is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 12 n=25,12,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 32 n=25,0,9 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 16 n=25,12,10 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Baseline n=25,12,0 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 20 n=24,0,10 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 4 n=24,11,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 28 n=23,0,10 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 8 n=25,11,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 24 n=25,0,10 | 4 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Baseline n=25,12,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 4 n=24,11,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 8 n=25,11,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 12 n=25,12,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 16 n=25,12,10 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 20 n=24,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 24 n=25,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 16 n=25,12,10 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 28 n=23,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - CLP Cohort - Entire Treatment Period (FAS) | Week 32 n=25,0,9 | 1 Participants |
Secondary
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS)
The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Baseline n=24,13,0 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 32 n=24,0,11 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 20 n=24,0,13 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 28 n=24,0,13 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 24 n=23,0,13 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 4 n=24,13,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 12 n=24,13,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 8 n=24,13,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 16 n=24,13,13 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 16 n=24,13,13 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Baseline n=24,13,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 4 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 8 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 12 n=24,13,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 24 n=23,0,13 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 20 n=24,0,13 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 28 n=24,0,13 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 16 n=24,13,13 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - LPP Cohort - Entire Treatment Period (FAS) | Week 32 n=24,0,11 | 3 Participants |
Secondary
Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS)
The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts (Finlay and Khan 1994). The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week, and the instrument requires 1 to 2 minutes for completion. Each item has four response categories ranging from 0 (not at all) to 3 (very much). Not relevant is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, and 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 16 n=24,13,11 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 12 n=24,13,0 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 20 n=24,0,11 | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 28 n=23,0,11 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 24 n=24,0,10 | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 4 n=24,13,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 8 n=24,13,0 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 32 n=23,0,10 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Baseline n=24,13,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 4 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Baseline n=24,13,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 8 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 12 n=24,13,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 16 n=24,13,11 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 24 n=24,0,10 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 20 n=24,0,11 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 28 n=23,0,11 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 16 n=24,13,11 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With Dermatology Life Quality Index Response Scores of 0 to 1 up to Week 32 - MLP Cohort - Entire Treatment Period (FAS) | Week 32 n=23,0,10 | 2 Participants |
Secondary
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA improvement. >=2 n=25,0,10 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA <=2 n=25,12,0 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA improvement >=2 n=25,12,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA 0/1 n=25,12,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA <=2 n=24,11,0 | 9 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA improvement. >=2 n=24,11,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA 0/1 n=24,11,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA <=2 n=25,11,0 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA improvement. >=2 n=25,11,0 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA 0/1 n=25,11,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA <=2 n=25,12,0 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA improvement. >=2 n=25,12,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA 0/1 n=25,12,0 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=25,12,10 | 11 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=25,12,10 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=25,12,10 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA <=2 n=24,0,10 | 11 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA improvement. >=2 n=24,0,10 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA 0/1 n=24,0,10 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA <=2 n=25,0,10 | 14 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA 0/1 n=25,0,10 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA <=2 n=23,0,10 | 12 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA improvement. >=2 n=23,0,10 | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA 0/1 n=23,0,10 | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA <=2 n=24,0,9 | 9 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA improvement. >=2 n=24,0,9 | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA 0/1 n=24,0,9 | 6 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=25,12,10 | 7 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=25,12,10 | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA <=2 n=25,12,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=25,12,10 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA improvement >=2 n=25,12,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA 0/1 n=25,12,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA <=2 n=24,11,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA improvement. >=2 n=24,11,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA 0/1 n=24,11,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA <=2 n=25,11,0 | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA improvement. >=2 n=25,11,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA 0/1 n=25,11,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA <=2 n=25,12,0 | 4 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA improvement. >=2 n=25,12,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA 0/1 n=25,12,0 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=25,12,10 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA 0/1 n=25,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA improvement. >=2 n=24,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=25,12,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA improvement. >=2 n=24,0,9 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA <=2 n=25,0,10 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA improvement. >=2 n=23,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA improvement. >=2 n=25,0,10 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=25,12,10 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA 0/1 n=24,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA <=2 n=23,0,10 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA 0/1 n=23,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA <=2 n=24,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA 0/1 n=24,0,9 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - CLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA <=2 n=24,0,9 | 2 Participants |
Secondary
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 or lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA improvement. >=2 n=24,13,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA 0/1 n=24,13,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA <=2 n=23,0,13 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA <=2 n==24,0,11 | 11 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA <=2 n=24,13,0 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA improvement >=2 n=24,13,0 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA 0/1 n=24,13,0 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA <=2 n=24,13,0 | 9 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA 0/1 n=24,13,0 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA <=2 n=24,13,0 | 8 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA improvement. >=2 n=24,13,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA 0/1 n=24,13,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA <=2 n=24,13,0 | 8 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA improvement. >=2 n=24,13,0 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=24,13,13 | 9 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=24,13,13 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=24,13,13 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA <=2 n=24,0,13 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA improvement. >=2 n=24,0,13 | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA 0/1 n=24,0,13 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA improvement. >=2 n=23,0,13 | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA 0/1 n=23,0,13 | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA <=2 n=24,0,13 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA improvement. >=2 n=24,0,13 | 6 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA 0/1 n=24,0,13 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA improvement. >=2 n==24,0,11 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA 0/1 n==24,0,11 | 4 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA improvement. >=2 n=24,13,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA 0/1 n=24,13,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=24,13,13 | 4 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=24,13,13 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA <=2 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA improvement >=2 n=24,13,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=24,13,13 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA 0/1 n=24,13,0 | 0 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA <=2 n=24,13,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA improvement. >=2 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA 0/1 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA <=2 n=24,13,0 | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA improvement. >=2 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA 0/1 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA <=2 n=24,13,0 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA 0/1 n=24,0,13 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=24,13,13 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA improvement. >=2 n=24,0,13 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA <=2 n=24,0,13 | 9 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=24,13,13 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA improvement. >=2 n=23,0,13 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA <=2 n=23,0,13 | 8 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA 0/1 n=23,0,13 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA 0/1 n=24,0,13 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA 0/1 n==24,0,11 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=24,13,13 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA <=2 n==24,0,11 | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA improvement. >=2 n==24,0,11 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA improvement. >=2 n=24,0,13 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - LPP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA <=2 n=24,0,13 | 6 Participants |
Secondary
Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS)
Number of subjects with IGA of 2 of lower, improvement in the IGA score of at least 2 points, or IGA score of 0/1. IGA is measured on a scale from 0-4 with 0=Clear, 1=minimal, 2=mild, 3=moderate, and 4=severe with 0 being best score and 4 being worst score.
Time frame: Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA 0/1 n=24,13,0 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA <=2 n=24,13,0 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=24,13,11 | 9 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA 0/1 n=23,0,10 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=24,13,11 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA improvement. >=2 n=24,13,0 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA <=2 n=23,0,11 | 7 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=24,13,11 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA improvement. >=2 n=23,0,11 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA 0/1 n=24,0,10 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA <=2 n=24,0,11 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA improvement. >=2 n=24,0,10 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA improvement. >=2 n=24,0,11 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA <=2 n=24,0,10 | 10 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA 0/1 n=24,0,11 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA 0/1 n=24,13,0 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA <=2 n=24,12,0 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA <=2 n=24,13,0 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA improvement. >=2 n=23,0,10 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA improvement. >=2 n=24,13,0 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA improvement >=2 n=24,12,0 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA 0/1 n=24,13,0 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA <=2 n=23,0,10 | 9 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA <=2 n=24,13,0 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA 0/1 n=24,12,0 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA improvement. >=2 n=24,13,0 | 5 Participants |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA 0/1 n=23,0,11 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA improvement. >=2 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA <=2 n=24,12,0 | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA improvement >=2 n=24,12,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 2 IGA 0/1 n=24,12,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA <=2 n=24,13,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 4 IGA 0/1 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA <=2 n=24,13,0 | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA improvement. >=2 n=24,13,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 8 IGA 0/1 n=24,13,0 | 1 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA <=2 n=24,13,0 | 4 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA improvement. >=2 n=24,13,0 | 4 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 12 IGA 0/1 n=24,13,0 | 2 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=24,13,11 | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=24,13,11 | 3 Participants |
| Placebo - TP 1 - CLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=24,13,11 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA 0/1 n=24,0,11 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA improvement. >=2 n=24,0,11 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA <=2 n=24,0,10 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 20 IGA <=2 n=24,0,11 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA improvement. >=2 n=24,0,10 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA 0/1 n=24,13,11 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 24 IGA 0/1 n=24,0,10 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 16 IGA improvement. >=2 n=24,13,11 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA <=2 n=23,0,11 | 4 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week16 IGA <=2 n=24,13,11 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA improvement. >=2 n=23,0,11 | 3 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA improvement. >=2 n=23,0,10 | 1 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA <=2 n=23,0,10 | 2 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 28 IGA 0/1 n=23,0,11 | 0 Participants |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Number (%) of Subjects With IGA ≤ 2 Response, IGA ≥2 Points Improvement Response, and IGA 0 or 1 Response by Visit - MLP Cohort (BOCF)- Entire Treatment Period (FAS) | Week 32 IGA 0/1 n=23,0,10 | 0 Participants |
Secondary
Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS)
The LPPAI assesses symptoms (pruritus, pain, burning), signs (erythema, perifollicular erythema and scale), a measure of activity (pull test) and extension of disease. These subjective and objective measures are assigned numeric values to establish a disease activity score. The total score ranges from 0 to 10, with higher scores corresponding to higher disease activity
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Week 32 n=24,0,13 | -2.44 scores on a scale | Standard Deviation 2.428 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Baseline n=24,13,13 | 5.92 scores on a scale | Standard Deviation 2.071 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Week 16 n=24,13,13 | -1.44 scores on a scale | Standard Deviation 2.517 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Week 16 n=24,13,13 | -2.24 scores on a scale | Standard Deviation 2.522 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Baseline n=24,13,13 | 5.95 scores on a scale | Standard Deviation 1.767 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Baseline n=24,13,13 | 5.95 scores on a scale | Standard Deviation 1.767 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Week 32 n=24,0,13 | -3.20 scores on a scale | Standard Deviation 2.927 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Lichen Planopilaris Activity Index (LPPAI)- LPP Cohort (BOCF) (FAS) | Week 16 n=24,13,13 | -2.24 scores on a scale | Standard Deviation 2.522 |
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 How bothered by Itch during past 24 hours n=25,0,9 | -1.1 scores on a scale | Standard Deviation 2.45 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 How severe was itch at worst moment during past 24 hours n=25,0,9 | -1.3 scores on a scale | Standard Deviation 2.13 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=25,12,10 | -0.9 scores on a scale | Standard Deviation 2.52 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=25,12,10 | -0.8 scores on a scale | Standard Deviation 1.91 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 1 | 5.1 scores on a scale | Standard Deviation 2.66 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=25,12,10 | -1.0 scores on a scale | Standard Deviation 2.65 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 Severity of itch during past 24 hours n=25,0,9 | -1.5 scores on a scale | Standard Deviation 2.24 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline- Question 3 | 4.8 scores on a scale | Standard Deviation 3.08 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline- Question 2 | 5.6 scores on a scale | Standard Deviation 2.72 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 1 | 5.7 scores on a scale | Standard Deviation 2.77 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=25,12,10 | -2.3 scores on a scale | Standard Deviation 3.25 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline- Question 2 | 6.3 scores on a scale | Standard Deviation 2.86 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=25,12,10 | -2.7 scores on a scale | Standard Deviation 3.73 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline- Question 3 | 6.1 scores on a scale | Standard Deviation 2.94 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=25,12,10 | -2.7 scores on a scale | Standard Deviation 3.55 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 How severe was itch at worst moment during past 24 hours n=25,0,9 | -1.2 scores on a scale | Standard Deviation 2.49 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 Severity of itch during past 24 hours n=25,0,9 | -1.1 scores on a scale | Standard Deviation 2.42 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 1 | 5.8 scores on a scale | Standard Deviation 3.01 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline- Question 3 | 6.1 scores on a scale | Standard Deviation 3.21 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=25,12,10 | -2.0 scores on a scale | Standard Deviation 3.53 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 How bothered by Itch during past 24 hours n=25,0,9 | -1.2 scores on a scale | Standard Deviation 2.28 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=25,12,10 | -2.4 scores on a scale | Standard Deviation 3.84 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=25,12,10 | -1.9 scores on a scale | Standard Deviation 3.54 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline- Question 2 | 5.9 scores on a scale | Standard Deviation 3.03 |
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 How bothered by Itch during past 24 hours n=24,0,11 | -1.7 scores on a scale | Standard Deviation 2.08 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 How severe was itch at worst moment during past 24 hours n=24,0,11 | -1.8 scores on a scale | Standard Deviation 2.23 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=24,13,13 | -0.7 scores on a scale | Standard Deviation 2.35 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=24,13,11 | -0.5 scores on a scale | Standard Deviation 2.25 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,13 | 4.5 scores on a scale | Standard Deviation 2.25 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=24,13,13 | -0.4 scores on a scale | Standard Deviation 2.43 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 Severity of itch during past 24 hours n=24,0,11 | -1.6 scores on a scale | Standard Deviation 2.06 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 4.0 scores on a scale | Standard Deviation 2.36 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 2 n=24,13,13 | 5.1 scores on a scale | Standard Deviation 2.43 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=24,13,13 | -1.3 scores on a scale | Standard Deviation 2.81 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,13 | 3.8 scores on a scale | Standard Deviation 2.68 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=24,13,11 | -1.1 scores on a scale | Standard Deviation 2.47 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 2 n=24,13,13 | 4.2 scores on a scale | Standard Deviation 2.86 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 3.2 scores on a scale | Standard Deviation 2.79 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=24,13,13 | -1.2 scores on a scale | Standard Deviation 3.02 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 How severe was itch at worst moment during past 24 hours n=24,0,11 | -2.6 scores on a scale | Standard Deviation 3.01 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 Severity of itch during past 24 hours n=24,0,11 | -2.4 scores on a scale | Standard Deviation 2.84 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,13 | 3.8 scores on a scale | Standard Deviation 2.68 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 3.2 scores on a scale | Standard Deviation 2.79 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=24,13,11 | -1.1 scores on a scale | Standard Deviation 2.47 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 How bothered by Itch during past 24 hours n=24,0,11 | -2.2 scores on a scale | Standard Deviation 2.44 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=24,13,13 | -1.2 scores on a scale | Standard Deviation 3.02 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=24,13,13 | -1.3 scores on a scale | Standard Deviation 2.81 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 2 n=24,13,13 | 4.1 scores on a scale | Standard Deviation 4.16 |
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS)
Itch is assessed with the following questions: • Overall, how severe was your lichen planus-related itching during the past 24 hours? • How severe was your lichen planus-related itching at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related itching during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no itch and 10 meaning the worst itch imaginable.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 32 How severe was itch at worst moment during past 24 hours n=22,0,10 | 0.3 scores on a scale | Standard Deviation 2.43 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 3.4 scores on a scale | Standard Deviation 3.41 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 32 Severity of itch during past 24 hours n=22,0,10 | 0.1 scores on a scale | Standard Deviation 2.97 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 32 How bothered by Itch during past 24 hours n=22,0,10 | -0.2 scores on a scale | Standard Deviation 1.33 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=23,13,11 | 2.5 scores on a scale | Standard Deviation 2.83 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=23,13,11 | 2.4 scores on a scale | Standard Deviation 2.9 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=23,13,11 | 0.8 scores on a scale | Standard Deviation 3.04 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=23,13,11 | 0.3 scores on a scale | Standard Deviation 3.26 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=23,13,11 | -0.5 scores on a scale | Standard Deviation 2.95 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 4.0 scores on a scale | Standard Deviation 4.14 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=23,13,11 | 3.8 scores on a scale | Standard Deviation 3.81 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=23,13,11 | -0.2 scores on a scale | Standard Deviation 3.41 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=23,13,11 | 0.1 scores on a scale | Standard Deviation 3.12 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=23,13,11 | 0.4 scores on a scale | Standard Deviation 3.25 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=23,13,11 | 3.6 scores on a scale | Standard Deviation 3.99 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 32 How bothered by Itch during past 24 hours n=22,0,10 | -0.4 scores on a scale | Standard Deviation 4.25 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=23,13,11 | 4.3 scores on a scale | Standard Deviation 3.93 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 Severity of itch during past 24 hours n=23,13,11 | -0.3 scores on a scale | Standard Deviation 3.72 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 32 Severity of itch during past 24 hours n=22,0,10 | -0.4 scores on a scale | Standard Deviation 3.37 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 How severe was itch at worst moment during past 24 hours n=23,13,11 | 0.4 scores on a scale | Standard Deviation 3.56 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 32 How severe was itch at worst moment during past 24 hours n=22,0,10 | 0.4 scores on a scale | Standard Deviation 3.81 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 4.5 scores on a scale | Standard Deviation 4.27 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Week 16 How bothered by Itch during past 24 hours n=23,13,11 | 0.0 scores on a scale | Standard Deviation 3.41 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Itch Using Numeric Rating Scale (NRS) by Question - MLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=23,13,11 | 4.1 scores on a scale | Standard Deviation 4.16 |
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=25,12,10 | 2.2 scores on a scale | Standard Deviation 2.48 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 How bothered by pain during past 24 hours n=25, 0,9 | -0.2 scores on a scale | Standard Deviation 1.71 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 How severe was pain at worst moment during past 24 hours n=25,0,9 | -0.4 scores on a scale | Standard Deviation 2.35 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=25,12,10 | 0.1 scores on a scale | Standard Deviation 2.03 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=25,12,10 | 0.2 scores on a scale | Standard Deviation 1.48 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=25,12,10 | 1.09 scores on a scale | Standard Deviation 2.05 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=25,12,10 | 0.1 scores on a scale | Standard Deviation 2.09 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 Severity of pain during past 24 hours n=25,0,9 | -0.3 scores on a scale | Standard Deviation 1.65 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=25,12,10 | 2.1 scores on a scale | Standard Deviation 2.55 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=25,12,10 | -0.6 scores on a scale | Standard Deviation 1.62 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=25,12,10 | 3.4 scores on a scale | Standard Deviation 2.61 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=25,12,10 | -0.8 scores on a scale | Standard Deviation 1.4 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=25,12,10 | 3.9 scores on a scale | Standard Deviation 3.23 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=25,12,10 | -1.2 scores on a scale | Standard Deviation 1.7 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=25,12,10 | 3.7 scores on a scale | Standard Deviation 2.96 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=25,12,10 | 3.9 scores on a scale | Standard Deviation 3.03 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 How severe was pain at worst moment during past 24 hours n=25,0,9 | -0.4 scores on a scale | Standard Deviation 2.7 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 Severity of pain during past 24 hours n=25,0,9 | -0.3 scores on a scale | Standard Deviation 2.29 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 32 How bothered by pain during past 24 hours n=25, 0,9 | -0.3 scores on a scale | Standard Deviation 2.45 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=25,12,10 | 3.8 scores on a scale | Standard Deviation 2.94 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=25,12,10 | -0.8 scores on a scale | Standard Deviation 1.48 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=25,12,10 | 0.5 scores on a scale | Standard Deviation 1.72 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=25,12,10 | 3.5 scores on a scale | Standard Deviation 2.51 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - CLP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=25,12,10 | -1.0 scores on a scale | Standard Deviation 1.56 |
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 2 24,13,12 | 2.8 scores on a scale | Standard Deviation 2.68 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 How bothered by pain during past 24 hours n=24,0,11 | -0.8 scores on a scale | Standard Deviation 1.79 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 How severe was pain at worst moment during past 24 hours n=24,0,11 | -0.8 scores on a scale | Standard Deviation 2.06 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,12 | 0.2 scores on a scale | Standard Deviation 3.16 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=24,13,12 | 0.3 scores on a scale | Standard Deviation 2.61 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,12 | 2.5 scores on a scale | Standard Deviation 2.43 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=24,13,12 | 0.0 scores on a scale | Standard Deviation 2.87 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 Severity of pain during past 24 hours n=24,0,11 | -0.6 scores on a scale | Standard Deviation 1.72 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,12 | 2.7 scores on a scale | Standard Deviation 2.56 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,12 | 2.4 scores on a scale | Standard Deviation 2.75 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,12 | 2.0 scores on a scale | Standard Deviation 2.38 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=24,13,12 | -0.5 scores on a scale | Standard Deviation 1.9 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 2 24,13,12 | 2.5 scores on a scale | Standard Deviation 2.73 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,12 | -0.9 scores on a scale | Standard Deviation 2.25 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=24,13,12 | -1.1 scores on a scale | Standard Deviation 2.25 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 2 24,13,12 | 2.5 scores on a scale | Standard Deviation 2.73 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 How severe was pain at worst moment during past 24 hours n=24,0,11 | -2.0 scores on a scale | Standard Deviation 2.45 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 Severity of pain during past 24 hours n=24,0,11 | -1.5 scores on a scale | Standard Deviation 2.02 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,12 | 2.4 scores on a scale | Standard Deviation 2.75 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=24,13,12 | -0.5 scores on a scale | Standard Deviation 1.9 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 32 How bothered by pain during past 24 hours n=24,0,11 | -1.9 scores on a scale | Standard Deviation 2.51 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=24,13,12 | -1.1 scores on a scale | Standard Deviation 2.25 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,12 | 2.0 scores on a scale | Standard Deviation 2.38 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question - LPP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,12 | -0.9 scores on a scale | Standard Deviation 2.25 |
Secondary
Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS)
Pain is assessed with the following questions: • Overall, how severe was your lichen planus-related pain during the past 24 hours? • How severe was your lichen planus-related pain at the worst moment during the past 24 hours? • Overall, how bothered were you by your lichen planus-related pain during the past 24 hours? Answers are given on a numeric rating scale (NRS) from 0 to 10, with 0 meaning no pain and 10 meaning the worst pain imaginable.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=24,13,11 | -0.5 scores on a scale | Standard Deviation 3.08 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 32 How severe was pain at worst moment during past 24 hours n=23,0,10 | -0.3 scores on a scale | Standard Deviation 2.06 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,11 | -0.5 scores on a scale | Standard Deviation 3.13 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,11 | 5.1 scores on a scale | Standard Deviation 2.86 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 32 How bothered by pain during past 24 hours n=23,0,10 | -0.5 scores on a scale | Standard Deviation 2.74 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=24,13,11 | -0.8 scores on a scale | Standard Deviation 3.54 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 32 Severity of pain during past 24 hours n=23,0,10 | -0.3 scores on a scale | Standard Deviation 2.18 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 5.5 scores on a scale | Standard Deviation 3.35 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=24,13,11 | 5.4 scores on a scale | Standard Deviation 2.99 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,11 | -0.3 scores on a scale | Standard Deviation 2.75 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,11 | 5.9 scores on a scale | Standard Deviation 3.09 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=24,13,11 | -0.1 scores on a scale | Standard Deviation 3.01 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=24,13,11 | 6.4 scores on a scale | Standard Deviation 3.15 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 6.5 scores on a scale | Standard Deviation 2.76 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=24,13,11 | -0.3 scores on a scale | Standard Deviation 2.21 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 32 How severe was pain at worst moment during past 24 hours n=23,0,10 | -0.5 scores on a scale | Standard Deviation 2.46 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 32 Severity of pain during past 24 hours n=23,0,10 | -0.6 scores on a scale | Standard Deviation 2.59 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 1 n=24,13,11 | 6.3 scores on a scale | Standard Deviation 3.23 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 3 n=24,13,11 | 6.8 scores on a scale | Standard Deviation 2.79 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 Severity of pain during past 24 hours n=24,13,11 | 0.0 scores on a scale | Standard Deviation 3.29 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 32 How bothered by pain during past 24 hours n=23,0,10 | -0.9 scores on a scale | Standard Deviation 2.69 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 How bothered by pain during past 24 hour n=24,13,11 | -0.1 scores on a scale | Standard Deviation 2.34 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Week 16 How severe was pain at worst moment during past 24 hours n=24,13,11 | -0.2 scores on a scale | Standard Deviation 2.99 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Patient Assessment of Pain Using Numeric Rating Scale (NRS) by Question -MLP Cohort (BOCF) (FAS) | Baseline - Question 2 n=24,13,11 | 6.7 scores on a scale | Standard Deviation 3.26 |
Secondary
Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS)
Scalpdex is a self-administered, health-related quality of life instrument originally developed for scalp dermatitis. This survey includes 23 items, each item scored on a scale of 0-100, where 0=never, 25=rarely, 50=sometimes, 75=often and 100=all the time. The 23 items pertain to 3 domains: symptom, emotions and functioning. Subjects were asked to score themselves on how true each of the 23 statements has been for them over the past four weeks. the total score is the average of the scores of the 23 items. A higher total score indicated a higher impairment in quality of life.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Week 16 n=24,13,12 | 1.86 scores on a scale | Standard Deviation 10.695 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Baseline n=24,13,12 | 55.75 scores on a scale | Standard Deviation 16.476 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Week 32 n=24,0,11 | -4.26 scores on a scale | Standard Deviation 12.876 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Week 16 n=24,13,12 | -6.94 scores on a scale | Standard Deviation 11.508 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Baseline n=24,13,12 | 54.01 scores on a scale | Standard Deviation 23.252 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Week 16 n=24,13,12 | -6.94 scores on a scale | Standard Deviation 11.508 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Baseline n=24,13,12 | 54.01 scores on a scale | Standard Deviation 23.252 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline for Scalpdex - LPP Cohort (BOCF) (FAS) | Week 32 n=24,0,11 | -14.43 scores on a scale | Standard Deviation 16.464 |
Secondary
Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period
OLPSSM is a self-administered assessment of the symptom experience of subjects with oral LP in clinical studies. It includes 7 triggers contributing to soreness of oral lichen planus: Brushing teeth, eating food, drinking liquids, smiling, breathing through mouth, talking and touching. These 7 items contributed equally to a total OLP symptom severity score, ranging from 0 to 28, with higher scores indicating worse severity.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 16 n=21,12,10 | -1.0 scores on a scale | Standard Deviation 6.82 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Baseline n=21,12,10 | 11.0 scores on a scale | Standard Deviation 5.98 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 32 n=20,0,9 | -1.8 scores on a scale | Standard Deviation 5.67 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 16 n=21,12,10 | 0.8 scores on a scale | Standard Deviation 6.47 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Baseline n=21,12,10 | 13.4 scores on a scale | Standard Deviation 5.5 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 16 n=21,12,10 | -0.4 scores on a scale | Standard Deviation 7.09 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Baseline n=21,12,10 | 13.9 scores on a scale | Standard Deviation 5.78 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline in Oral Lichen Planus Symptom Severity Measure (OLPSSM) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 32 n=20,0,9 | -0.7 scores on a scale | Standard Deviation 7 |
Secondary
Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period
REU measured disease severity based on 3 dimensions: reticulation, erythema and ulceration for all subjects in the MLP cohort who had an oral presentation of the disease. The total score ranged from 0-115 with higher values corresponding to higher activity of the disease.
Time frame: Baseline, Week 16 and Week 32
Population: Full analysis set. Patients who were included in FAS for TP1 were included in FAS for TP2 except that the placebo patients in spontaneous remission at Week 16 were excluded from Placebo- AIN457 300 mg Q2W TP2 group. Patients who discontinued study treatment before week 32 were imputed using baseline observation carried forward. Missing values not related to treatment discontinuation were analyzed as observed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 16 n=21,12,10 | -4.83 scores on a scale | Standard Deviation 11.102 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Baseline n=21,12,10 | 21.31 scores on a scale | Standard Deviation 8.747 |
| AIN457 300 mg Q4W - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 32 n=20,0,9 | -6.08 scores on a scale | Standard Deviation 10.206 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 16 n=21,12,10 | -5.79 scores on a scale | Standard Deviation 14.476 |
| Placebo - TP 1 - CLP Cohort | Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Baseline n=21,12,10 | 25.29 scores on a scale | Standard Deviation 9.102 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 16 n=21,12,10 | -4.10 scores on a scale | Standard Deviation 15.196 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Baseline n=21,12,10 | 26.95 scores on a scale | Standard Deviation 8.855 |
| AIN457 300 mg Q4W - TP 1 - MLP Cohort | Summary of Baseline Score and Change From Baseline in Reticular Erythematous Ulcerative Score (REU) - MLP Cohort - (BOCF) - Entire Treatment Period | Week 32 n=20,0,9 | -2.17 scores on a scale | Standard Deviation 15.802 |